Status:
COMPLETED
ACtive Catheterization for EndovaScular TreatmentS
Lead Sponsor:
Basecamp Vascular
Conditions:
Unruptured Intracranial Aneurysm
Arteriovenous Cerebral Malformations
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular acce...
Detailed Description
The Basecamp Vascular trial is a prospective monocenter, non-randomized, open clinical investigation of their controllable directional GECKO guidewire which has not yet received the CE mark. The GECKO...
Eligibility Criteria
Inclusion
- Male or female ≥18 years old.
- An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis.
- Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center.
- Subject is eligible to undergo a procedure with the use of contrast media.
- Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
- Subject has given written informed consent.
- Life expectancy \>12 months.
Exclusion
- Subject is unconscious and unable to directly provide his/her written informed consent.
- Subject with a type 3 aortic arch will be excluded from the study.
- Subject is or has been treated with radiation therapy to the neck or chest.
- Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
- Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib).
- Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
- Subject is unable to complete the required follow-up.
- Subject is pregnant or breastfeeding. (Females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
- Subject has participated in a clinical study within the last 30 days.
- Subject with cardiac pacemaker or defibrillator.
- Persons under guardianship or curatorship.
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05355259
Start Date
June 27 2022
End Date
August 5 2022
Last Update
November 3 2022
Active Locations (1)
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1
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019